Davita Sturgeon Bay Dialysis

“IC-WEAR GLOVES/HAND HYGIENE CFR(s): 494.30(a)(1) Wear disposable gloves when caring for the patient or touching the patient’s equipment at the dialysis station. Staff must remove gloves and wash hands between each patient or station. This Standard is not met as evidenced by: 29972 Based on record review, observation, and interview staff failed to perform hand hygiene after removing gloves, between glove changes, and before touching “clean” equipment and obtaining clean supplies in 4 of 8 patient observations (Patient (Pt) #1, 6, 7, 8), in a total sample of 8 patients observed; failed to wear gloves while handling biohazardous supplies in 1 of 1 observation of blood collection (Pt #8) in a total of 1 lab collection observed; and failed to ensure patients perform hand hygiene after dialysis treatment using an Arteriovenous Fistula/Graft (AVF/G) in 1 of 1 patients observed holding their access site post treatment (Pt #10), in a total sample of 2 patients observed with an AVF/G post treatment. Findings Include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last reviewed April 2023 revealed the following: -“All Teammates...will perform hand hygiene...b. prior to gloving and immediately after removal of gloves...d. after patient and dialysis delivery system contact...g. before touching clean areas such as supplies, supply cart and chairside keyboard/mouse.” - “Patients and caregivers will be encouraged to...b. Perform hand hygiene after treatment before leaving treatment areas.” - “Disposable glove will be worn when caring for the patient or touching the patient’s equipment at the dialysis station...a. Gloves should be changed when: ...ii. When going from a “dirty” area or task to a “clean” area or task...iv. After touching one patient or their dialysis delivery system and before arriving to care for another patient or touch another patient’s dialysis delivery system.” - “The chair side cart...monitor and keyboard are considered clean areas.” Staff observations: On 08/26/2025 beginning at 11:30 AM, observed Patient Care Technician (PCT) E initiating Pt #7’s dialysis treatment using an AVF/G. PCT E adjusted her face shield with potentially contaminated gloves (6 times) during Pt #7’s vascular access cannulation and while connecting the bloodlines to initiate treatment. PCT E did not remove gloves and perform hand hygiene before touching her face shield. On 08/26/2025 beginning at 11:40 AM, observed Patient Care Technician (PCT) G initiating Pt #6’s dialysis treatment using an Central Venous Catheter (CVC). PCT G cleaned Pt #6’s CVC exit site then obtained clean gauze from the nurses station without first removing gloves and performing hand hygiene. On 08/26/2025 beginning at 12:30 PM, observed PCT E setting up the dialysis machine at Station 2; wearing the same gloves PCT E proceeded to obtain her face shield and adjust Pt #1’s vascular access clamp at Station 4, allowing for potential cross contamination; PCT E did not remove gloves, perform hand hygiene, and don a clean pair of gloves before touching Pt #1’s vascular access site. On 08/27/2025 beginning at 10:29 AM, observed PCT F initiating Pt #8’s dialysis. PCT F touched the machine with gloved hands (4 times) to silence the alarm; then removed the gloves and placed the “dirty” gloves on the computer cart next to the keyboard. PCT F did not immediately dispose of the “dirty” gloves and perform hand hygiene after removing gloves and between glove changes. 08/27/2025 beginning at 10:29 AM, observed PCT F drawing labs off of Pt #8’s blood lines. PCT F collected the blood in the lab tubes then placed the lab tubes on the tray table. PCT F touched her face shield with the potentially contaminated gloves, then removed the gloves and did not perform hand hygiene. PCT F proceeded to take Pt #8’s lab tubes to the lab room without wearing gloves to prevent potential cross contamination. Patient observation: On 08/26/2025 beginning at 11:41 AM, observed Registered Nurse (RN) C discontinuing Pt #10’s dialysis treatment using an AVF/G. Pt #10 donned a glove and proceeded to hold pressure on his access site to achieve hemostasis (stop bleeding). Pt #10 did not perform hand hygiene after removing glove and before exiting the dialysis treatment area. During interview on 08/27/2025 beginning at 4:00 PM, while discussing observations with Facility Administrator (FA) A; FA A stated that staff should be performing hand hygiene and wear gloves as per policy, and that staff should ensure that patients are performing hand hygiene after glove removal and before leaving the facility. FA A stated that staff should remove gloves and perform hand hygiene before touching face shield.”

“IC-GOWNS, SHIELDS/MASKS-NO STAFF EAT/DRINK CFR(s): 494.30(a)(1)(i) Staff members should wear gowns, face shields, eye wear, or masks to protect themselves and prevent soiling of clothing when performing procedures during which spurting or spattering of blood might occur (e.g., during initiation and termination of dialysis, cleaning of dialyzers, and centrifugation of blood). Staff members should not eat, drink, or smoke in the dialysis treatment area or in the laboratory. This Standard is not met as evidenced by: 29972 Based on record review, observation, and interview the facility staff failed to wear personal protective equipment (PPE) appropriately to protect from potential blood splatter and contaminants in 1 of 5 observations of staff (Registered Nurse (RN) C), in a total of 5 staff observed. Findings Include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last reviewed April 2023 revealed the following: - “Appropriate PPE will be worn whenever there is potential for contact with body fluids...contaminated equipment and environmental surfaces...” - “Appropriate fluid resistant/fluid impervious gowns will be worn by all teammates...when in the treatment area.” On 08/26/2025 beginning at 3:05 PM, observed Registered Nurse (RN) C administering Pt #7’s intravenous medication via Pt #7’s blood lines attached to the dialysis machine. RN C did not wear a face shield protecting her from potential blood splatter and contaminants. During interview on 08/27/2025 beginning at 4:00 PM, while discussing observations with Facility Administrator (FA) A; FA A stated that RN C should have been wearing her face shield while administering IV medications during dialysis.”

“IC-DISINFECT SURFACES/EQUIP/WRITTEN PROTOCOL CFR(s): 494.30(a)(4)(ii) [The facility must demonstrate that it follows standard infection control precautions by implementing- (4) And maintaining procedures, in accordance with applicable State and local laws and accepted public health procedures, for the-] (ii) Cleaning and disinfection of contaminated surfaces, medical devices, and equipment. This Standard is not met as evidenced by: 29972 Based on observation, record review and interview, the facility staff failed to clean and disinfect all the equipment at the dialysis station between patients to prevent potential cross contamination in 2 of 2 observations of dialysis station cleaning (Station (St) #3, 8), in a total sample of 2 observations of station cleaning; and failed to ensure that potentially contaminated surfaces are cleaned and disinfected after contact with potentially “dirty” supplies/equipment in 3 of 5 staff observed (Patient Care Technician (PCT) E, PCT F, PCT G), in a total of 5 staff observed. Findings Include: Review of policy and procedure #1-05-01 titled, “Infection Control for Dialysis Facilities” last reviewed April 2023 revealed the following: -“At the end of each treatment, the dialysis station will be cleaned and disinfected.” - “a. Surfaces to disinfect include but are not necessarily limited to: all surfaces in contact with the patient or their belongings (e.g., dialysis chair, tray tables, blood pressure cuffs) and frequently contacted by healthcare personnel (e.g., control panel, top, front and sides of dialysis machine; touchscreens; countertops)...the Wall box, drain, and water supply lines are considered part of the dialysis delivery system.” - “Non-disposable items are to be disinfected after each patient use, prior to removal from treatment area/station and if contaminated between uses. If item cannot be cleaned and disinfected it will be dedicated for use on a single patient.” Station Cleaning: On 08/26/2025 at 11:11 AM, observed PCT E cleaning and disinfecting Station #8. PCT E did not clean the screen attached to the dialysis machine. On 08/26/2025 at 11:50 AM, observed PCT G cleaning and disinfecting Station #3. PCT G did not clean the following: -Counter tops at the station -Plastic evacuation bag hanging from the TV -IV pole and hooks -Stethoscope hanging from the IV pole Face Shield: On 08/26/2025 beginning at 11:30 AM, observed Patient Care Technician (PCT) E initiating Pt #7’s dialysis treatment using an Arteriovenous Fistula/Graft. PCT E adjusted her face shield with potentially contaminated gloves (6 times) during Pt #7’s vascular access cannulation and while connecting the bloodlines to initiate treatment. PCT E removed her face shield and placed it on the “clean” computer keyboard, allowing for potential cross contamination of clean equipment. PCT E did not clean and disinfect the keyboard between patients. On 08/26/2025 beginning at 11:50 AM, observed PCT G setting up the dialysis machine at Station #3. PCT G removed her gloves (no hand hygiene), then removed her face shield and placed it on the “clean” computer keyboard, allowing for potential cross contamination of clean equipment. PCT G did not clean and disinfect the keyboard between patients. 08/27/2025 beginning at 10:29 AM, observed PCT F drawing labs off of Pt #8’s blood lines. PCT F collected the blood in the lab tubes then placed the lab tubes on the tray table. PCT F removed her face shield, touching the face shield with the potentially contaminated gloves, then placed the face shield on the “clean” computer keyboard; allowing for potential cross contamination of clean equipment. PCT F did not clean and disinfect the keyboard between patients. During interview with Facility Administrator (FA) A on 08/27/2025 at 4:00 PM, while discussing observations, FA A stated that staff should be removing glove and performing hand hygiene before touching the face shields. FA A stated that staff should not place the face shield on the computer keyboard. FA A stated the computer keyboard is considered “clean” and is not cleaned between patients.”

“IC-STAFF EDUCATION-CATHETERS/CATHETER CARE CFR(s): 494.30(a)(2) Recommendations for Placement of Intravascular Catheters in Adults and Children I. Health care worker education and training A. Educate health-care workers regarding the ... appropriate infection control measures to prevent intravascular catheter-related infections. B. Assess knowledge of and adherence to guidelines periodically for all persons who manage intravascular catheters. II. Surveillance A. Monitor the catheter sites visually of individual patients. If patients have tenderness at the insertion site, fever without obvious source, or other manifestations suggesting local or BSI [blood stream infection], the dressing should be removed to allow thorough examination of the site. Central Venous Catheters, Including PICCs, Hemodialysis, and Pulmonary Artery Catheters in Adult and Pediatric Patients. VI. Catheter and catheter-site care B. Antibiotic lock solutions: Do not routinely use antibiotic lock solutions to prevent CRBSI [catheter related blood stream infections]. This Standard is not met as evidenced by: 29972 Based on record review, observation and interview, the facility staff failed to ensure Central Venous Catheters (CVCs) are accessed in a manner to prevent potential cross contamination in 1 of 2 patients observed with a CVC (Patient (Pt) #6) in a total sample of 2 patients observed with a CVC. Findings include: Review of policy and procedures #1-04-02B titled, “Central Venous Catheter....” last reviewed April 2025 revealed the following: - “Clean each CVC limb/cap with new large alcohol prep pad, starting close to the exit site and finishing with the cap - “Perform a 15 second hub scrub of the CVC during the process of connecting or disconnecting from the blood lines, including line reversal, or if the patient is disconnected during treatment for any reason.” - Scrub the CVC Hubs with a “70% Alcohol pad” for “15 seconds” and allow to air dry. On 08/26/2025 beginning at 11:40 AM, observed PCT G initiating Pt #6’s dialysis using a CVC. PCT G did not clean the CVC limbs starting close to the exit site down to the caps/hubs as per policy. PCT G did not scrub the arterial CVC hub with an alcohol wipe and PCT G scrubbed the venous CVC hub for 7 seconds, not 15 seconds per hub as per policy. During interview on 08/27/2025 beginning at 4:00 PM, while discussing observations with Facility Administrator (FA) A; FA A stated that staff should be cleaning the catheter limbs from the exit site down to the hub and then scrub the hubs for 15 seconds each with an alcohol wipe as per policy.”

“PA-APPROPRIATENESS OF DIALYSIS RX CFR(s): 494.80(a)(2) The patient’s comprehensive assessment must include, but is not limited to, the following: (2) Evaluation of the appropriateness of the dialysis prescription, This Standard is not met as evidenced by: 29972 Based on record review and interview staff failed to ensure Heparin is administered as per physician orders in 4 of 4 in-center hemodialysis patients with Heparin orders (Patients (Pt) #1, #2, #3, #4), in a total sample of 5 medical records reviewed. Findings include: Review of policy and procedure #1-06-02 titled, “Anticoagulation” last reviewed September 2024 revealed the following: - “Heparin is administered per physician’s order.” - “A Heparin pump is used to deliver a constant infusion of Heparin over the course of the hemodialysis treatment...” - “It is recommended that the heparin hourly infusion be discontinued 60 minutes prior to end of treatment for patients with arterio-venous (AV) fistulas and/or AV grafts per physician order. It is recommended that the heparin hourly infusion be continued for the entire treatment for patients with CVCs.” Review of Pt #1’s Treatment Sheets revealed treatment orders for a Heparin infusion of 1000 units per hour and stopped at 0 minutes before the end of treatment. Review of Pt #1’s Treatment Sheets revealed the following: -08/25/2025: Treatment time was 4 hours and 6 minutes and the total Heparin infusion given was documented as 3500 units; Pt #1 should have been given 4000 units (1000 units x 4 hours). -08/22/2025: Treatment time was 4 hours and the total Heparin infusion given was documented as 3500 units; Pt #1 should have been given 4000 units. Review of Pt #2’s Treatment Sheets revealed treatment orders for a Heparin infusion of 1000 units per hour and stopped at 0 minutes before the end of treatment. Review of Pt #1’s Treatment Sheets revealed the following: -08/20/2025: Treatment started at 1:05 PM and ended at 3:56 PM (2 hours and 48 minutes); the Heparin infusion was documented as stopped at 4:12 PM, this was 16 minutes after treatment ended. Documentation revealed Pt #2 received a total Heparin infusion of 2100 units; however, treatment time was 2 hours and 48 minutes so Pt #2 should have received approximately 2800 units of Heparin (2.8 hours x 1000 units). Review of Pt #3’s Treatment Sheets revealed treatment orders for a Heparin infusion of 600 units per hour and stopped 60 minutes before treatment ends. Review of Pt #3’s Treatment Sheets revealed the following: -08/25/2025: Treatment ended at 4:06 PM and the Heparin infusion was documented as stopped at 2:25 PM; this was 91 minutes before treatment ended (order for 60 minutes before). Documentation revealed Pt #3 received a total Heparin infusion of 1200 units; however, treatment started at 12:54 PM (Heparin stopped at 2:25 PM) and Pt #3 received 1 hour and 31 minutes of Heparin, which should be approximately 900 units infused not 1200 units. Review of Pt #4’s Treatment Sheets revealed treatment orders for a Heparin infusion of 1000 units per hour and stopped 60 minutes before treatment ends. Review of Pt #4’s Treatment Sheets revealed the following: -08/26/2025: Treatment ended at 1:07 PM and the Heparin infusion was documented as stopped at 1:17 PM, 10 minutes after treatment ended (should be 60 minutes before). During interview on 08/27/2025 beginning at 4:00 PM, while discussing medical record findings with Facility Administrator (FA) A; FA A confirmed the findings and stated that staff should be administering Heparin as per physician orders.”

“POC-MANAGE VOLUME STATUS CFR(s): 494.90(a)(1) The plan of care must address, but not be limited to, the following: (1) Dose of dialysis. The interdisciplinary team must provide the necessary care and services to manage the patient’s volume status; This Standard is not met as evidenced by: 29972 Based on record review and interview, the facility staff failed to ensure that nursing staff perform nursing assessments and interventions when blood pressure (BP) is out of parameters in 1 of 4 In-Center Hemodialysis medical records reviewed (Patient (Pt) #3); failed to monitor patient’s blood pressure and fluid status during treatment as per policy in 2 of 4 In-Center Hemodialysis medical records reviewed (Pt #1, #4); and failed to address abnormal Fluid status post treatment in 3 of 4 In-Center Hemodialysis medical records reviewed (Pt #1, #2, #4), in a total sample of 5 medical records reviewed. Findings Include: Review of policy and procedure #1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” last reviewed April 2024 revealed; - “Abnormal findings or findings outside of any patient specific physician ordered parameters will be reported to the licensed nurse immediately. The licensed nurse will use his/her clinical judgement based on individual patient needs to determine if any clinical interventions are necessary.” - “If an abnormal finding or concern is identified post treatment, this needs to be reported to the licensed nurse. The licensed nurse will assess the patient prior to discharge.” - “All findings, interventions and patient response will be documented in the patient’s medical record.” - Abnormal findings include: Fluid Status Pre-Treatment...”Removal goal not to exceed maximum ordered by physician...Post-treatment: If patient is above or below 1 kilogram from the target weight (TW);” - Abnormal Findings include: Blood Pressure-Intradialytic (during treatment)...”Systolic (blood pressure) greater than 180...or less than 90...Diastolic (blood pressure) greater than or equal to 100 or less than 50...” -“Vital signs and treatment monitoring...is completed at least every 30 minutes...At a minimum, obtain and document the following:...Blood pressure...Heart or pulse rate...blood and dialysis flows...fluid removal and or replacement...” In-Center Hemodialysis BP assessments and monitoring: Review of Pt #1’s Treatment Sheets revealed: -On 08/25/2025 Pt #1’s vital signs were checked at 9:17 AM and then not again until 11:20 AM, 2 hours and 3 minutes later; should be a minimum of every 30 minutes per policy. Review of Pt #4’s Treatment Sheets revealed: -On 08/26/2025 Pt #4’s vital signs were checked at 11:36 AM and then not again until 12:36 PM, 1 hour later. Review of Pt #3’s Treatment sheets revealed: -On 08/18/2025 at 3:24 PM Pt #3’s Systolic Blood Pressure (SBP) was 88 (ordered parameters greater than 100); there was no documentation of the nurse assessing and addressing Pt #3’s abnormal SBP. Fluid: Review of Pt #1’s Treatment Sheets revealed the Maximum Fluid Removal Goal during treatment was 4000 milliters (ml). Review of Pt #1’s Treatment sheet dated 08/20/2025 revealed that 4508 ml of fluid was removed during treatment. There was no documentation recognizing and addressing why more fluid was removed than ordered by the physician. Review of Pt #2’s Treatment Sheets revealed that Pt #2’s ordered target weight was 68.5 kilograms (kg). Review of Pt #2’s Treatment Sheet dated 08/20/2025 revealed Pt #2’s post weight was 2.1 kg above the target weight. There was no documentation of nursing interventions recognizing and addressing Pt #2 being more than 1 kg above target weight as per policy. Review of Pt #4’s Treatment Sheets revealed that Pt #4’s ordered target weight was 150 kg. Review of Pt #4’s Treatment Sheets revealed: -On 08/26/2025 Pt #4’s post weight was 3.2 kg above the target weight. There was no documentation of nursing interventions recognizing and addressing Pt #4 being more than 1 kg above target weight as per policy. -On 08/23/2025 Pt #4’s post weight was 3.5 kg above the target weight. There was no documentation of nursing interventions recognizing and addressing Pt #4 being more than 1 kg above target weight as per policy. -On 08/21/2025 Pt #4’s post weight was 3.1 kg above the target weight. There was no documentation of nursing interventions recognizing and addressing Pt #4 being more than 1 kg above target weight as per policy. During interview on 08/27/2025 beginning at 4:00 PM, while discussing medical record findings with Facility Administrator (FA) A; FA A confirmed the findings and stated that if a patient is above 1 kilogram from the target weight post dialysis nursing staff should document interventions and notify the physician.”

“POC-ACHIEVE ADEQUATE CLEARANCE CFR(s): 494.90(a)(1) Achieve and sustain the prescribed dose of dialysis to meet a hemodialysis Kt/V of at least 1.2 and a peritoneal dialysis weekly Kt/V of at least 1.7 or meet an alternative equivalent professionally-accepted clinical practice standard for adequacy of dialysis. This Standard is not met as evidenced by: 29972 Based on record review and interview, the facility staff failed to follow prescribed blood flow rates (BFR) for 2 of 4 In-center Hemodialysis medical records reviewed (Patient (Pt) #1, #3), in a total sample of 5 medical records reviewed. Findings Include: Review of policy and procedure #1-03-08 titled, “Pre-Intra-Post Treatment Data Collection, Monitoring and Nursing Assessment” last reviewed April 2024 revealed the following: -“If the dialysis prescription is not being met (including dialysis flow rate or change to/inability to obtain prescribed blood flow rate) the reason will be documented and the licensed nurse informed.” A review of Pt #1’s Treatment Sheets revealed orders for a BFR of 400. Review of Pt #1’s Treatment Sheets revealed the following: -On 08/25/2025 the BFR was set at 300 during the entire dialysis treatment; there was no documentation recognizing and addressing Pt #1 not dialyzing at the ordered BFR. -On 08/22/2025 the BFR was set at 350 during the entire dialysis treatment; there was no documentation recognizing and addressing Pt #1 not dialyzing as per physician ordered BFR. A review of Pt #3’s Treatment Sheets revealed orders for a BFR of 350. Review of Pt #3’s Treatment Sheets revealed the following: -On 08/25/2025 the BFR was set between 200 and 250 during the entire dialysis treatment; there was no documentation recognizing and addressing Pt #3 not dialyzing at the ordered BFR. -On 08/18/2025 the BFR was set at 300 during the entire dialysis treatment; there was no documentation recognizing and addressing Pt #3 not dialyzing at the ordered BFR. During interview with Facility Administrator (FA) A on 08/27/2025 at 4:00 PM, while discussing medical record findings, FA A confirmed the findings and stated that the BFR should be set as per physician orders. FA A stated that if staff are not able to maintain the ordered BFR, they should document the interventions and inform the nurse. Per FA A the physician should be notified if the staff are unable to achieve the BFR and this should be documented.”

“POC-VASCULAR ACCESS-MONITOR/REFERRALS CFR(s): 494.90(a)(5) The interdisciplinary team must provide vascular access monitoring and appropriate, timely referrals to achieve and sustain vascular access. The hemodialysis patient must be evaluated for the appropriate vascular access type, taking into consideration co-morbid conditions, other risk factors, and whether the patient is a potential candidate for arteriovenous fistula placement. This Standard is not met as evidenced by: 29972 Based on record review, observation, and interview staff failed to perform skin antisepsis prior to cannulation as per policy in 1 of 2 observations of treatment initiation using an AVF/G (Patient (Pt) #7); failed to inspect and evaluate the AVF/G access site before cannulation in 1 of 2 observations of treatment initiation using an AVF/G (Pt #8); and failed to assess the AVF/G after applying a clamp as per policy in 1 of 2 observations of treatment discontinuation using an AVF/G (Pt #9), in a total sample of 4 patients observed with an AVF/G. Findings Include: Review of policy and procedure #1-04-01D titled, AV Fistula or Graft Cannulation...” last reviewed April 2025 revealed the following: - “Perform inspection, auscultation and palpation on entire length of access. Determine presence of bruit and thrill (indicates blood flow through the access).” - Skin antiseptic--Povidone Iodine (betadine); effective contact/scrub time is 30 seconds. Review of policy and procedure #1-04-08A titled, “Utilizing Vascular Access Clamp Procedure” last reviewed April 2023 revealed the following: -“After placement of clamp, check for thrill (feel vibration indicating movement of blood) and bruit (sound of blood moving through access) above and below clamp. If thrill cannot be palpated or bruit heard, release clamp slightly and recheck until thrill can be palpated or bruit heard.” -“Clamp may remain in place for 5-10 minutes before checking to see if bleeding has stopped.” AVF/G: On 08/26/2025 beginning at 11:30 AM, observed Patient Care Technician (PCT) E initiating Pt #7’s dialysis treatment using a AVF/G. PCT E cleansed the skin over the cannulation sites (arterial and venous) with povidone iodine (betadine) antiseptic for 15 seconds both sites; not 30 seconds as per policy. On 08/27/2025 beginning at 10:29 AM, observed PCT F initiating Pt #8’s dialysis treatment using a AVF/G. PCT F did not evaluate the vascular access and check for the presence of a bruit and thrill as per policy. Clamps: On 08/26/2025 at 11:24 AM, observed PCT G discontinuing Pt #9’s dialysis treatment using an AVF/G. PCT G applied a clamp to Pt #9’s AVF/G and did not check for the presence of a bruit and thrill to ensure the access site was not occluded. PCT G applied the clamp at 11:28 AM and did not remove the clamp and check if bleeding stopped until 11:46 AM; 18 minutes later (per policy should be 5 to 10 minutes). During interview on 08/27/2025 beginning at 4:00 PM, while discussing observations with Facility Administrator (FA) A; FA A stated that staff should perform the skin antisepsis as per policy and the PCT should check for the bruit and thrill prior to cannulating. FA A stated the the clamp should not be on longer than 10 minutes before staff check if bleeding stopped.”

“QAPI-MEASURE/ANALYZE/TRACK QUAL INDICATORS CFR(s): 494.110(a)(2) The dialysis facility must measure, analyze, and track quality indicators or other aspects of performance that the facility adopts or develops that reflect processes of care and facility operations. These performance components must influence or relate to the desired outcomes or be the outcomes themselves. This Standard is not met as evidenced by: 29972 Based on record review and interview, the facility staff failed to ensure that quality data is tracked, trended, and/or analyzed to address issues with Fluid and Blood Pressure management, Mortality, Hospitalizations, and Hospital Readmissions in 2 of 2 Quality Assessment and Performance Improvement (QAPI) programs reviewed (In-Center Hemodialysis, Peritoneal Dialysis), in a total of 2 QAPI programs reviewed. Findings include: Review of policy #5-15-06 titled, “Continuous Quality Improvement Program” last revised April 2024 revealed the following: -Written documentation and plans of action will be documented within the FHM (Facility Health Meeting) application known as Facility Health Record (FHR)...Copies of the QI (Quality Improvement) meeting minutes will be provided upon request to CMS (Centers for Medicare and Medicaid). - “The facility will measure, analyze, and track quality indicators or other aspects of performance. The program must include, but not limited to, the following:...Mortality-review of deaths, Hospitalizations...Other indicators as reflected in the Quality Improvement and Facility Management Meeting minutes form.” - “Continuous monitoring of the above indicators will be reflected in the meeting minutes. Any area identified as underperforming will be reviewed to identify root causes for underperformance, will have an action plan identified that will result in performance improvement...” Fluid and Blood Pressure Management: Review of the FHR Fluid management dashboard for In-center Hemodialysis (HD) and Peritoneal Dialysis, revealed in the May 2025, June 2025, and July 2025 FHM, the interdisciplinary team (IDT) did not document evidence of continuous monitoring, tracking, and analyzing quality indicators for Blood Pressure management. Mortality: Review of Mortality reviews revealed there was 1 death in May 2025 and 1 death in June 2025. Review of the Mortality dashboard revealed in the June 2025 and July 2025 FHR, the IDT did not document evidence of discussing all deaths in FHM. Hospitalizations and Readmissions < 30 days: Review of the Hospitalization log revealed that there were 3 hospitalizations and 1 readmission in May 2025 and 6 hospitalizations and 3 readmissions in June 2025. Review of the FHR Hospitalizations dashboard, revealed in the June 2025 and July 2025 FHR, the IDT did not document evidence of trending and analyzing Hospitalizations and Readmissions < 30 days. During interview with Facility Administrator (FA) A, while discussing QAPI on 08/28/2025 beginning at 8:30 AM, FA A confirmed the findings and stated that the IDT does not typically discuss blood pressure tracking, trending, and analyzing in FHM. FA A stated that the IDT should be discussing all deaths and hospitalizations and readmissions in FHM and this should be documented in the FHR.”

“MD RESP-ENSURE ALL ADHERE TO P&P CFR(s): 494.150(c)(2)(i) The medical director must- (2) Ensure that- (i) All policies and procedures relative to patient admissions, patient care, infection control, and safety are adhered to by all individuals who treat patients in the facility, including attending physicians and nonphysician providers; This Standard is not met as evidenced by: 29972 Based on record review, interview, and observation the facility staff failed to ensure nursing staff verify medication orders prior to medication administration as per policy in 1 of 2 medication administration observations (Patient (Pt) #7), in a total of 2 medication administrations observed. Findings Include: Review of policy and procedure #1-06-01 titled, “Medication Policy” last revised November 2023 revealed, “Prior to administration of medication, verify physician...order. Check for patient allergies when receiving or entering a medication order and prior to administering any medications.” On 08/26/2025 at 3:05 PM, observed Registered Nurse (RN) C administering an intravenous (IV) medication to Pt #7. RN C did not check the medication to the order in the electronic medical record prior to administering the IV medication. During interview with Facility Administrator (FA) A on 08/27/2025 beginning at 4:00 PM, while discussing observations, FA A stated that the nurse should verify the medication order in the patients electronic medical record prior to administration.”

“GOV-STAFF HAVE ACCESS TO CONTINUING ED CFR(s): 494.180(b)(4) The governing body or designated person responsible must ensure that- (4) All employees have an opportunity for continuing education and related development activities This Standard is not met as evidenced by: 29972 Based on interview and record review, the facility staff failed to ensure that staff training and competencies are up to date in 3 of 4 personnel files reviewed (Patient Care Technician (PCT) H, PCT E, Registered Nurse (RN) I), in a total of 4 personnel files reviewed. Findings Include: Review of policy and procedure titled, “Teammate Qualifications, Licensure...” last revised October 2017 revealed: - “The dialysis facility’s teammates will meet the personnel qualifications and demonstrated competencies necessary to serve collectively the comprehensive needs of the patients.” Review of PCT H’s personnel files revealed, PCT H’s annual “Procedural Skills Verification Checklist” was last completed on 07/26/2024 (more than 12 months ago). Review of PCT E’s personnel files revealed, PCT E’s annual “Procedural Skills Verification Checklist” was last completed on 04/22/2024 (more than 12 months ago). Review of Peritoneal Dialysis (PD) RN I’s personnel files revealed PD RN I’s last competencies were documented as completed on 04/23/2024 (more than 12 months ago). During interview with Facility Administrator (FA) A while reviewing personnel files on 08/27/2025 beginning at 9:40 AM, FA A stated that the competency skills checklist and education should be done annually and stated that they are behind on completing annual competencies and training.”